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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO., LTD. MCKESSON BRANDS; SYRINGE, LL 60CC
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JIANGSU CAINA MEDICAL CO., LTD. MCKESSON BRANDS; SYRINGE, LL 60CC Back to Search Results
Catalog Number 102-S60C
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 02/08/2023
Event Type  Injury  
Event Description
The customer reported that they have had 3 stem collections that reported positive for citrobacter bacteria which is not normal for their collection history.They reported that they are trying to investigate all materials that are used during the collection process.This report is being filed in reference to the mckesson brands syringes that are used in transferring a small volume of fluid to the stem cell collection bag as part of the collection process.
 
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Brand Name
MCKESSON BRANDS
Type of Device
SYRINGE, LL 60CC
Manufacturer (Section D)
JIANGSU CAINA MEDICAL CO., LTD.
no. 23 huanxi rd
zhutang town, jiangyin city
CH 
MDR Report Key16485194
MDR Text Key310689845
Report Number1451040-2023-00010
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number102-S60C
Device Lot NumberCJCA12-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/06/2023
Distributor Facility Aware Date02/08/2023
Device Age15 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer03/06/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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